• 計畫中文名稱 建立中藥境內品質管制中心(機制)
• 計畫英文名稱 Domestic Quality Control Center of Chinese Herbal Medicine in Taiwan (Mechanism)
• 系統編號 PG9411-0052 • 研究性質 其他
• 計畫編號 CCMP94-CP-102 • 研究方式 委託研究
• 主管機關 行政院衛生署 • 研究期間 9411 ~ 9412
• 執行機構 台北醫學大學藥學系
• 年度 94 年 • 研究經費 991 千元
• 研究領域 藥學, 生物技術
• 研究人員 楊玲玲,林承斌,梁文俐,林俊茂,陳均元,陳立耿,王靜瓊
• 中文關鍵字 中藥境內品質管制中心；中藥品質管制；異樣通報管制
• 英文關鍵字 domestic quality control center of Chinese medicine in Taiwan；quality control of Chinese herbal medicine；peculiar reporting control system
• 中文摘要
本計畫-『建立中藥境內品質管制中心』執行期間，預計在 94 至 95 年間將由台灣北部縣市針對每種藥材進行採樣，採樣之樣品數將包 含境外認證及無認證之藥材，其中具有自境外認證品質管理機制所認證的實驗室出具之成績書的樣品將至少有 5 %，共預計進行 94 年兩種及 95 年一種中藥材，以評估預計全面實施之規範，市售品合格率為何？並定義『異樣』。收集藥材之相關化學及藥理之文獻，
彙整檢驗結果，召開產、官、學專家會議討論，研訂一套境內管制機制及建立異樣通報管制平台。預計完成之項目： 1. 三種包含境 外認證之藥材文獻收集 2. 完成三種市售品藥材之品質調查(包含境外認證及境內無認證) 3. 成立產官學專家小組與宣導會議 研訂一 套『境內管制機制及建立異樣通報管制平台』
• 英文摘要
In this grant "Domestic Quality Control Center of Chinese Medicine in Taiwan", will collect 7 crude drugs from northern Taiwan Chinese medicinal drug's stores and investigate the quality control analysis from 2005 to 2006. Two kinds of Crude drug's raw material in 2005 and one kind in 2006 and the analysis protocols will accord to the CCMP route. Furthermore, each crude drug of related references will search for the chemical constituents, pharmacological activities, processing, and distribution and merge the results of the detection results. It will be also held the meeting include the experts from industry, government and research fields and set up a domestic quality control mechanism and set up a platform for the domestic mechanism and establish the platform for peculiar reporting quality control. The items of goals are described as following, 1. Search for the references of the domestic three identified materials of Chinese medicines from the crude drug's market. 2. To finish
the investigation of quality control analysis on the three commercial raw material of Chinese medicines (Offshore identified and domestic unidentified materials of Chinese medicines) 3. To establish the expert group meeting and instructed meeting include the experts from industry, government and research fields. Finally, the goal is to establish a model of "domestic quality control mechanism and to build up a platform for peculiar reporting quality control".
